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A Study of the Real-life Management of Psoriasis Patients Treated With Otezla® (Apremilast) in Belgium (OTELO)

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ClinicalTrials.gov Identifier: NCT03097003
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

OTELO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing study. The study will include a representative sample of approximately 250 patients with moderate-to-severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label and reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after commencing the study treatment.

As this study is non-interventional, drug dosing and treatment duration will be at the sole discretion of the treating dermatologist, in accordance with the local label and daily clinical practice.


Condition or disease Intervention/treatment
Psoriasis Drug: Apremilast

Detailed Description:

Patient care will follow routine clinical practice, involving regular follow-up visits, without any mandatory visit. In daily practice, patients are usually seen by their treating dermatologists every 3 months. In this study, patients will be followed-up for a least 6 months and at most 18 months after apremilast treatment initiation. Considering that Belgian National Institute for Health and Disability Insurance (NIHDI) queries have to be addressed by 31st January 2019, patient data will be collected until May/June 2018. Assuming a recruitment phase of 12-month duration starting as of December 2016, individual patient follow-up times will range from 6 to 18 months, depending on the inclusion date.

During the study, it is expected to collect data at inclusion and at 6 months after apremilast initiation in all patients. As per National Institute for Health and Disability Insurance (NIHDI) recommendations, patients should consult their treating dermatologists 6 months after apremilast initiation in order to evaluate treatment response and decide on treatment continuation for an additional period of 12 months. For patients recruited early in the study, data will be collected during the next follow-up visits up to 18 months after apremilast initiation. Only data pertaining to visits occurring at 9 (± 1), 12 (± 1), 15 (±1), and 18 (± 1) months after treatment initiation will be collected. If a study visit occurs approximately 3 (± 1) months after treatment initiation, the data will also be recorded.

All clinical data collected during this non-interventional study will be routinely documented in the patient's medical records, which are the main source of information. The study data will be collecting via an eCRF. Data from source documents including PRO-questionnaires will be entered in the eCRF by the investigator or other authorised appropriately designed and trained study site personnel. Data entered into the eCRF will be reviewed for consistency by the Data Manager using both automated logical checks (issuing in automatic queries generated by the system) and manual review (issuing in manual checks set by the Data Manager or the Monitor into the eCRF). All data collected within the eCRF will be approved and electronically signed and dated by the Investigator or designee. At the conclusion of the study, before the final statistical analysis, the eCRF and other study data will be locked to further additions or corrections.

During the study, the Clinical Research Associate (CRA) will contact each study site on a regular basis in order to check the progress and conduct of the study. If issues regarding study conduct arise, additional on-site visits may be performed. In particular, a quality analysis will also be performed and based on data quality, it will be decided whether on-site monitoring is necessary, for which site and on which percentage of patients. During monitoring visits, eCRFs, patient's source documents, and all other study documentation will be reviewed by the CRA. Accuracy will be checked by performing source data verification that is a direct comparison of the entries made onto the eCRF against the appropriate source documentation.

Adverse events AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The detailed methodology of the statistical analyses will be documented in a statistical analysis plan (SAP). The SAP will be written by the Clinical Research Organisation (CRO) in charge of the study and will be validated by sponsor prior to performing the analysis and obligatory before the database lock. A scientific committee has been selected for this study. This committee will provide advice on the SAP.


Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of the Real-life Management of Psoriasis Patients Treated With Otezla® (Apremilast) in Belgium
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Group/Cohort Intervention/treatment
Use of Apremilast in patient with plaque psoriasis
Psoriasis patients treated with Otezla® (Apremilast) in Belgium
Drug: Apremilast
Psoriasis patients treated with Otezla® (Apremilast) in Belgium




Primary Outcome Measures :
  1. Proportion of patients with Patient Benefit Index for skin diseases (standard version) (PBI-S) ≥ 1 at 6 months after apremilast initiation. [ Time Frame: Up to 6 Months ]
    The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.


Secondary Outcome Measures :
  1. Characteristics of the patients treated with apremilast [ Time Frame: Baseline ]
    The patients treated with Apremilast will be described according to the following characteristics: demographics (age, gender, weight, height, and ethnicity), professional status, lifestyle habits, medical history (including psoriasis treatment history), and comorbidities

  2. Proportion of patients with PBI-S = 4 at 6 months after apremilast initiation [ Time Frame: Up to 6 Months ]
    The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.

  3. PBI-S outcome score after apremilast initiation [ Time Frame: up to 18 months ]
    The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.

  4. Proportion of patients having clear/no psoriasis based on Patient Global Assessment (PtGA) at 6 months after apremilast initiation [ Time Frame: up to 6 months ]
    PtGA is defined as single-item 5-point categorised scale reflecting the patient's overall impression of psoriasis severity. This scale ranges from 0 (clear/no psoriasis) to 4 (severe psoriasis)

  5. Change from baseline in the PtGA after apremilast initiation [ Time Frame: up to 18 months ]
    PtGA is defined as single-item 5-point categorised scale reflecting the patient's overall impression of psoriasis severity. This scale ranges from 0 (clear/no psoriasis) to 4 (severe psoriasis)

  6. Proportion of patients with Dermatology Life Quality Index (DLQI) ≤ 5 at 6 months after apremilast initiation. [ Time Frame: Up to 6 Months ]
    DLQI is 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Each item is graded on a Likert scale of 0−3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.

  7. Change from baseline in the DLQI score after apremilast initiation [ Time Frame: up to 18 months ]
    DLQI is 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Each item is graded on a Likert scale of 0−3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.

  8. Change from baseline in the psoriasis symptomatology [ Time Frame: up to 18 months ]
    Psoriasis symptomatology - pruritus, scalp psoriasis, nail psoriasis, skin discomfort/pain, joint pain, fatigue, overall wellbeing. Each symptom will be graded using a 7-grade discrete rating scale

  9. Change from baseline in the patient-reported treatment satisfaction (TSQM-9) [ Time Frame: up to 18 months ]
    TSQM-9 is 9-item validated self-administered questionnaire used to evaluate the patient's overall satisfaction with study treatment. The TSQM-9 consists of 8 items that make up 3 specific scales (effectiveness, side effects, convenience) and one global satisfaction scale. Scale scores are transformed into scores from 0 to 100 with higher scores representing higher satisfaction in that domain.

  10. Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 or PASI 75 at 6 months after apremilast initiation [ Time Frame: Up to 6 Months ]
    PASI is common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis. PASI 50 and PASI 75 responses were defined as >=50% and >= 75% improvement in overall PASI score when compared to baseline

  11. Change from baseline in the disease activity scores in terms of Body Surface Area (BSA) [ Time Frame: up to 18 months ]
    BSA is measurement of the body area involved in relation to the whole body surface.

  12. Change from baseline in the disease activity scores in terms of PASI [ Time Frame: up to 18 months ]
    PASI is common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis. PASI 50 and PASI 75 responses were defined as >=50% and >= 75% improvement in overall PASI score when compared to baseline

  13. Mean duration of apremilast treatment in biologic-naïve patients and in patients having received a previous biological treatment [ Time Frame: Up to 18 Months ]
    Time to the stop of the treatment by Apremilast will be calculated as the time interval from the date of apremilast initiation to the date of the apremilast stop

  14. Rate of discontinuation of apremilast treatment within 6 months after initiation [ Time Frame: Up to 6 months ]
    Descriptive statistics will be provided for the rate and reasons for discontinuation of treatment within 6 months. This analysis will be performed on safety population and restricted to patients who stop the treatment before the time point to analyse or for which the follow-up is at least so long as the time point to analyse.

  15. Adverse Events (AEs) [ Time Frame: Up to 18 months ]
    Number of participants with adverse event



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with moderate-to-severe plaque psoriasis visiting dermatology practices in Belgium and eligible for treatment with apremilast according to the local label and reimbursement criteria.

Patients may be enrolled into the study up to 4 weeks after commencing the treatment with apremilast. The decision to treat the patient with apremilast will be made prior to the decision to enter the patient into the study.

Criteria

Inclusion Criteria:

- Patients who meet ALL the following criteria can be enrolled:

  • Male or female aged at least 18 years.
  • With a diagnosis of moderate-to-severe chronic plaque psoriasis. As per Belgian National Institute for Health and Disability Insurance (NIHDI), moderate-to-severe plaque psoriasis in adult patients is defined by a Body Surface Area (BSA) > 10% or aPsoriasis Area and Severity Index (PASI) > 10.
  • For whom the treating dermatologist has made the decision to commence apremilast treatment in accordance with the local label and reimbursement criteria
  • Able to follow the instructions of the study.
  • Having signed an Informed Consent Form (ICF)

Exclusion Criteria:

Patients who meet AT LEAST one of the following exclusion criteria will be excluded:

  • Patients who have received apremilast > 4 weeks prior to the enrolment visit.
  • Women who are pregnant, breastfeeding or planning on becoming pregnant.
  • Non-menopausal women who are not using an adequate contraception method.
  • Patients with hypersensitivity to apremilast or to one of its excipients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097003


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Belgium
AZ Sint Jan Not yet recruiting
Brugge, Belgium, 8000
CHU St Pierre Recruiting
Brussels, Belgium, 1000
CHU Brugmann (Victor Horta) Recruiting
Brussels, Belgium, 1020
Clin Univ de Bxl Hôpital Erasme Recruiting
Brussels, Belgium, 1070
UZ Brussel Recruiting
Brussels, Belgium, 1090
Cliniques Universitaires St-Luc Recruiting
Brussels, Belgium, 1200
UZ Antwerpen Recruiting
Edegem, Belgium, 2650
Private Practice Geel Recruiting
Geel, Belgium, 2440
Private Practice Genk Recruiting
Genk, Belgium, 3600
AZ Sint Lucas Not yet recruiting
Gent, Belgium, 9000
UZ Gent Not yet recruiting
Gent, Belgium, 9000
CHU UCL Mont-Godinne Recruiting
Godinne, Belgium, 5530
Clinique André Renard d'Herstal Recruiting
Herstal, Belgium, 4040
Private Practice Lede Recruiting
Lede, Belgium, 9340
UZ Leuven Sint Rafael Recruiting
Leuven, Belgium, 3000
CHU Sart-Tilman Not yet recruiting
Liège, Belgium, 4000
GHdC - site IMTR Recruiting
Loverval, Belgium, 6280
Dermatologie Maldegem Recruiting
Malgegem, Belgium, 9990
Private Practice Mons Recruiting
Mons, Belgium, 7000
Private Practice Namur Not yet recruiting
Namur, Belgium, 5000
Ste Elisabeth - Namur Not yet recruiting
Namur, Belgium, 5000
CH Bois Abbaye-Hesbaye Not yet recruiting
Seraing, Belgium, 4100
Sponsors and Collaborators
Celgene
Investigators
Study Director: Christophe Tessier, MD Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03097003     History of Changes
Other Study ID Numbers: CC-10004-PSOR-016
U1111-1194-1580 ( Other Identifier: WHO )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Proriasis
Real-life management
Observational
Otezla
CC-10004
Apremilast
Belgium
OTELO

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents